NCT07147166 Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
| NCT ID | NCT07147166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Gender Dysphoria |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2032-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2025-02-03 with a primary completion date of 2032-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 19 2. Undergoing double incision gender affirming mastectomy 3. Ability to adhere to Brijjit therapy after surgery 4. Willing to return for follow-up visits and undergo study evaluations Exclusion Criteria: 1. History of keloid formation 2. Radiation therapy history 3. Prior surgeries of the chest or breast 4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids 5. Active smoker 6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes) 7. Any other condition determined by PI to preclude subject from joining study
Contact & Investigator
Esther A Kim, MD
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT07147166 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Gender Dysphoria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07147166 currently recruiting?
Yes, NCT07147166 is actively recruiting participants. Contact the research team at nathan.ramrakhiani@ucsf.edu for enrollment information.
Where is the NCT07147166 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07147166 clinical trial?
NCT07147166 is sponsored by University of California, San Francisco. The principal investigator is Esther A Kim, MD at Study Principal Investigator. The trial plans to enroll 78 participants.